Companion Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The Companion Diagnostics Market is Segmented by Technology (Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), Real-time PCR (RT-PCR), Gene Sequencing, and Other Technologies), Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma, and Other Indications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Report Offers the Value (in USD million) for the Above-mentioned Segments.

Market Snapshot

Companion Diagnostics Market Size
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 20.4 %

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Market Overview

The companion diagnostics market was valued at USD 5,936.4 million in 2021, and it is projected to register a CAGR of 20.40% during the forecast period.

Early diagnosis of COVID-19 is becoming essential in the market, as it can help find the right treatment for patients impacted by the virus. The most commonly used and reliable test for diagnosis of COVID-19 is the polymerase chain reaction (PCR) test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs. Thus, the disease diagnosis using polymerase chain reaction (PCR) emerged as a major focus for managing the disease.​​ For instance, in November 2020, TScan Therapeutics signed a research license and option agreement with Qiagen to develop a COVID-19 immune response test. This led to increased adoption of companion diagnostics, thereby driving the growth of the market during the pandemic.

The companion diagnostics market is expected to experience substantial growth due to the rise in product launches, development of new biomarkers for various diseases, a rise in research and development of targeted therapies, an increase in demand for customized medicine with increased recognition in developing markets, and a higher number of unmet cancer care needs. For instance, in September 2020, Roche introduced a highly effective SARS-CoV-2 antibody test that provides fast results. The introduction of such highly effective diagnostic tests is expected to boost the market growth.

The growth of the global companion diagnostics market can be attributed to the rising focus on personalized medicine and the co-development of drug and diagnostic technologies. Moreover, the rising cases of adverse drug reactions related to drugs due to the lack of efficacy drive the need for companion diagnostics.

Globally, the rising burden of cancer increases the demand and awareness for personalized medicines among the population. With companies expanding their collaborations for better biomarkers and diagnostics to focus on cost regulations, there has been a significant number of opportunities for applications in indications like cancer, cardiovascular, and neurological disorders. For instance, in June 2020, Thermo Fisher Scientific Inc. and Agios Pharmaceuticals entered a strategic partnership to co-develop a second companion diagnostics platform for oncology.

Thus, the growing R&D activities in the development of novel diagnostic tests for various chronic diseases are anticipated to drive the growth of the global companion diagnostics market.

However, the high cost of drug development and associated clinical trials and reimbursement issues in many countries are expected to constrain the market growth.

Scope of the Report

As per the scope of the report, companion diagnostic tests provide information that is essential for the safe and effective use of a corresponding drug or biological product. The companion diagnostics market is segmented by technology (immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), gene sequencing, and other technologies), indication (lung cancer, breast cancer, colorectal cancer, leukemia, melanoma, and other indications) and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above-mentioned segments.

By Technology
Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
In-situ Hybridization (ISH)
Real-time PCR (RT-PCR)
Gene Sequencing
Other Technologies
By Indication
Lung Cancer
Breast Cancer
Colorectal Cancer
Leukemia
Melanoma
Other Indications
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

The Lung Cancer Segment is Expected to Hold a Significant Share in the Market over the Forecast Period

Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer. Patients with lung cancer who receive companion diagnostics as part of their initial treatment have greater survival benefits than those not tested.

In 2020, the outbreak of SARS-CoV-2 (COVID-19) was one of society's greatest public health crises. Moreover, lung cancer patients represented a significant challenge in clinical diagnosis and treatment decision-making in the context of the highly contagious COVID-19 pandemic. For instance, according to a research article by Zhou Sha et al., published in Annals of Palliative Medicine Journal 2020, there was a significant impact of the COVID-19 crisis on oncological care, indicating the need for an appropriate change of treatment decisions and continued follow-up and psycho-oncological support during the pandemic.

Globally, the high incidence rate of non-small cell lung cancer (NSCLC), coupled with a rise in the development of oncology companion diagnostic tests for the disease, is expected to boost the market growth. For instance, in May 2020, the United States Food and Drug Administration approved the FoundationOne CDx assay for use with Capmatinib to treat metastatic non-small cell lung cancer (NSCLC). In addition, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib), a novel therapeutic option developed by Amgen.

The emergence of immunotherapy has given rise to the development of CDXs. Therascreen EGFR RGQ PCR Kit (Qiagen) and Cobas EGFR Mutation Test v2 (Roche Molecular Systems) are some of the many companion diagnostics available for lung cancer therapies.

Moreover, lung cancer is the most common form of cancer, and it causes the most cancer-related deaths globally. As per the 2020 data by Globocan, there were around 2,206,771 (11.4%) new lung cancer cases and 1,796,144 (18%) deaths due to lung cancer in 2020, leading to more demand for lung cancer companion diagnostics, which is expected to help the market growth over the forecast period.

Therefore, the rising prevalence of lung cancers and product launches for lung cancer companion diagnostics are expected to drive the growth of this segment.

Companion Diagnostics Market Trends

North America is Expected to Hold a Major Market Share Over the Forecast Period

North America dominated the overall companion diagnostics market, with the United States emerging as the major contributor to the market. The use of companion diagnostics is considered an important treatment decision tool for various oncology drugs, which is also reflected in how the FDA classifies these assays concerning risk.

Companion diagnostics clinical trials have come to the forefront in the pharmaceutical industry, despite the COVID-19 outbreak, as it helps boost the chances of clinical success. The testing kit has been seeing high demand for identifying those infected with SARS-CoV-2. The novel coronavirus remained the main focus for diagnostic test makers in terms of research and development. In 2020, in the United States, MiraDx set up its lab to provide COVID-19-based test services. The company claims that the lab has been able to analyze more than 9,000 tests accurately.

The increasing burden of cancer in the United States is also expected to drive market growth. According to the data published by American Cancer Society Inc., in January 2020, in the United States, there were around 1.8 million new cancer cases diagnosed and 606,520 cancer deaths.

In addition, the favorable reimbursement scenario for breast cancer diagnostic solutions in the United States is anticipated to facilitate their adoption. For instance, in January 2020, the Centers for Medicare & Medicaid Services (CMS) expanded its coverage of next-generation sequencing as a diagnostic tool for patients with germline (inherited) breast cancer.

Moreover, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence. This will further lead to drive the market growth over the forecast period in North America.

Owing to the above-mentioned factors, North America is expected to hold a major share in the global companion diagnostics market.

Companion Diagnostics Market Growth

Competitive Landscape

The companion diagnostics market is moderately fragmented and highly competitive with several major players. The rising focus of companies toward personalized medicine, co-development activities, and increased cases of adverse drug reactions are expected to boost the competitive rivalry in the market studied. The major market players, such as Abbott Laboratories Inc., Agilent Technologies Inc., F Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, are increasing the overall competitive rivalry of the market studied.

Recent Developments

  • In February 2022, Genetron Holdings Limited, a leading precision oncology platform company in China that specializes in molecular profiling tests, early cancer screening products, and companion diagnostics development, entered a collaboration agreement with HUTCHMED (China) Limited to develop a companion diagnostic (CDx).
  • In January 2022, Amoy Diagnostics Co. Ltd and PREMIA Holdings (HK) Limited launched the AmoyDx Pan Lung Cancer PCR Panel (the “PLC Panel”) in Japan as a reimbursed companion diagnostic for multiple anti-cancer agents.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Companies Promoting Personalized Medicine and Targeted Therapy as a New Treatment Option

      2. 4.2.2 Increasing Cases of Adverse Drug Reactions

      3. 4.2.3 Co-development of Drug and Diagnostic Technology

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of Drug Development and Associated Clinical Trials

      2. 4.3.2 Reimbursement Issues among Many Countries

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Technology

      1. 5.1.1 Immunohistochemistry (IHC)

      2. 5.1.2 Polymerase Chain Reaction (PCR)

      3. 5.1.3 In-situ Hybridization (ISH)

      4. 5.1.4 Real-time PCR (RT-PCR)

      5. 5.1.5 Gene Sequencing

      6. 5.1.6 Other Technologies

    2. 5.2 By Indication

      1. 5.2.1 Lung Cancer

      2. 5.2.2 Breast Cancer

      3. 5.2.3 Colorectal Cancer

      4. 5.2.4 Leukemia

      5. 5.2.5 Melanoma

      6. 5.2.6 Other Indications

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. 5.3.4.1 GCC

        2. 5.3.4.2 South Africa

        3. 5.3.4.3 Rest of Middle-East and Africa

      5. 5.3.5 South America

        1. 5.3.5.1 Brazil

        2. 5.3.5.2 Argentina

        3. 5.3.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories Inc.

      2. 6.1.2 Agilent Technologies Inc.

      3. 6.1.3 F.Hoffmann-La Roche Ltd

      4. 6.1.4 Biomerieux SA

      5. 6.1.5 Qiagen NV

      6. 6.1.6 Siemens Healthcare

      7. 6.1.7 Thermo Fisher Scientific Inc.

      8. 6.1.8 Danaher Corporation (Beckman Coulter Inc.)

      9. 6.1.9 Almac Group

      10. 6.1.10 Illumina Inc.

      11. 6.1.11 Myriad Genetics Inc.

      12. 6.1.12 Sysmex Corporation

      13. 6.1.13 Abnova Corporation

      14. 6.1.14 Guardant Health Inc.

      15. 6.1.15 Biogenex Laboratories Inc.

    2. *List Not Exhaustive
**Competitive Landscape covers Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Companion Diagnostics Market market is studied from 2019 - 2027.

The Global Companion Diagnostics Market is growing at a CAGR of 20.4% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

F Hoffmann-La Roche Ltd, Qiagen NV, Abbott Laboratories Inc, Agilent Technologies Inc., Biomerieux SA are the major companies operating in Global Companion Diagnostics Market.

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